Histologically confirmed and inoperable or irresectable metastatic colorectal cancer (stage IV) MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AIO-Studien-gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed and inoperable or irresectable metastatic colorectal cancer (stage IV) - Measurable lesion according to RECIST measured within 4 weeks prior to registration of the subject for the study Not allowed prior treatments - Previous chemotherapy for metastatic disease (adjuvant therapy for non-metastasized disease is allowed if terminated more than 6 months ago and without recurrence within 6 months after the end of adjuvant treatment) - Prior radiation of indicator lesion(s), except for documented progression during radiation and termination of radiotherapy at least 4 weeks prior to entry into the study - 18 years and over - ECOG 0-2 - No past or current history of malignancies except for the indication under this study and curatively treated: o Basal and squamous cell carcinoma of the skin o In-situ carcinoma of the cervix o Other malignant disease without recurrence after at least 5 years of follow-up - No severe internal disease (insufficiently treated or uncontrolled arterial hypertension, hemoptoe, NYHA grade II or greater congestive heart failure, symptomatic coronary heart disease, myocardial infarction (= 12 months prior to inclusion), serious cardiac arrhythmia requiring medication, peripheral arterial occlusive disease stage II or greater, uncontrolled severe disease) - No history or evidence upon physical examination of CNS disease unless adequately treated - No pre-existing neuropathy >= grade 1 (NCI CTCAE), except for loss of tendon reflex as the only symptom - No interstitial pneumonia or symptomatic fibrosis of the lung - No allogenic transplantation requiring immuno-suppressive therapy - No severe non-healing wounds, ulcers or bone fractions - No thrombosis or severe bleeding within 6 months prior to entry into the study (except for bleeding of the tumor before its surgical resection) and no evidence of bleeding diathesis or coagulopathy. - Patients not receiving therapeutic anticoagulation must have an INR = 1,500/µl - Platelets >= 100,000/µl - Hb >= 9g/dl (may be transfused to maintain or exceed this level) - Serum creatinine clearance > 50ml/min (Cockroft/Gault) - Serum total bilirubin: = 325 mg or NSAIDs, known to inhibit platelet function Other - No major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, nor anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration, which must be inserted at least 2 days prior to treatment start. With the only exception of a high remission pressure in case of synchronous metastases in just resected colorectal cancer,
Exclusion criteria
Exclusion criteria: See with E.2 Principal inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy. The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression. Primary end-point: Time to failure of maintenance and reinduction treatment strategy measured from randomization. ;Secondary Objective: Secondary end-points: - Time to failure of strategy from enrolment - Toxicity: Incidence, onset, duration, severity - Quality of life - Progression-free survival (PFS 1) - Progression-free survival during reinduction treatment (PFS 2) - Objective response rate due to first induction - Objective response rate on reinduction treatment - Treatment free interval / duration of maintenance therapy - Secondary resection rate with curative intent - Reasons for discontinuation of treatment - Overall survival - Translational research: immunohistochemistry, protein and gene expression parameters, proteomics and epigenetics; circulating tumour cells. ;Primary end point(s): AIO-KRK-0207 (Main study): Time to failure of maintenance and reinduction treatment strategy measured from randomization. Quality of life evaluation: Difference in the mean value of the global quality of life dimension of the EORTC QLQ C30, calculated as the average of all available time points from 6 weeks to 24 weeks after start of maintenance treatment or treatment interruption. | — |
Countries
Germany
Outcome results
None listed